Attachment mechanism for docking cannulas to surgical robotic arms

ABSTRACT

An apparatus for attachment of a cannula to a robotic surgical system, the apparatus comprising: a clamp operable to transition between an open position configured to receive a cannula and a closed position to attach the cannula to a robotic surgical system; an actuator operable to transition the clamp between the open position and the closed position; and a linking member pivotally coupled to the camp at a first pivot point and the actuator at a second pivot point, and wherein in the closed position, the second pivot point is over center relative to the first pivot point.

TECHNICAL FIELD

This disclosure relates generally to the field of robotic surgery and,more particularly, to systems and methods for surgical arm docking.

BACKGROUND

Minimally-invasive surgery (MIS), such as laparoscopic surgery, involvestechniques intended to reduce tissue damage during a surgical procedure.For example, laparoscopic procedures typically involve creating a numberof small incisions in the patient (e.g., in the abdomen), andintroducing one or more tools and at least one endoscopic camera throughthe incisions into the patient. The surgical procedures are thenperformed by using the introduced tools, with the visualization aidprovided by the camera. Generally, MIS provides multiple benefits, suchas reduced patient scarring, less patient pain, shorter patient recoveryperiods, and lower medical treatment costs associated with patientrecovery. In some embodiments, MIS may be performed with robotic systemsthat include one or more robotic arms for manipulating surgicalinstruments based on commands from an operator.

During a robotic MIS, a surgeon or other operator may use a number ofdifferent surgical instruments to perform a procedure at a surgicalsite. Oftentimes, a surgeon may rely on the use of a trocar or a cannulato target a site within a patient's body. The cannula may provide achannel or opening through which additional surgical instruments may beintroduced and removed by a surgeon. For example, a cannula can bepositioned within a patient in a body cavity, and a surgical instrumentcan be inserted into the cannula and guided to the body cavity via thecannula. In a robotic system, the cannula may be mounted to one or morerobotic arms, which may be remotely controlled by the surgeon to movethe cannula. A cannula mount may be used to attach the cannula to arobotic arm to ensure proper control and placement of the cannula withinthe patient.

SUMMARY

In MIS procedures, once a cannula of a trocar is properly positioned andinserted through tissue and into an interior region of a patient, arobotic arm, or a tool drive, is attached to the cannula to provide arigid mechanical attachment of the robotic arm and the cannula. Suchattachment of the robotic arm and the cannula can, for example, providestabilisation of the cannula such that one or more surgical tools can beinserted through a lumen of the cannula and into the interior region ofthe patient. In this regard, an attachment device or docking interfacelocated on a distal block of the robotic arm/tool drive is maneuvereduntil the attachment device is aligned with an attachment portion (e.g.,a cannula lug) of the cannula exposed outside the patient. Theattachment device or interface of the robotic arm/tool drive is thenlatched (or clamped) to the attachment portion of the cannula to providethe rigid mechanical attachment of the robotic arm/tool drive and thecannula.

The robotic arm (on a surgical table or on a cart) may be manually orautonomously guided toward the cannula within the surgical port(incision) by the surgical staff or the surgeon. The goal is to “dock”the surgical arm to the cannula/trocar to establish a rigid connectionand then deploy surgical tools through the access channel. Because ofthe delicate nature of interacting with surgical incision and theconfined space in the operating room, this operation should be carriedout by one person with one hand on the robot and one hand on thecannula. The user's ability to grab the arm, however, is limited by thecannula latch (e.g., lever or actuator of the attachment device)position and the arm geometry. For example, the latch might not beaccessible in all configurations and the geometry of the arm mightprovide pinch points. In one aspect, an improved way of docking an armis provided which maintains a mechanical connection, allowing the userto grab the arm anywhere he/she wants, and provides audible, tactile,and visual feedback on the success of the task. Representatively, adocking interface or attachment device is provided that automaticallysteps through the three required states during arm to cannula docking.The states are: 1) lock-out open position that allows the user to signalto the system that “docking mode” is in process, 2) mechanical detectionthat a cannula latch is in the correct position for docking, 3)automatic clamping of the cannula latch and signaling to the user.Representatively, the attachment device may include a lever or actuatorcoupled to the clamp that has a lock-out mechanism that, when triggeredby the user, keeps the clamp in the open configuration (open position).This configuration is maintained until a cannula is “mechanically”detected and the mechanisms automatically steps through the clampingaction.

In another aspect, the system may include sensing and logic fordetecting the docking of the cannula to the surgical robotic arms usingthe attachment device.

Representatively, a group of sensors may be integrated into theattachment device or interface that drive a finite state machine todetect presence of the cannula, proper latching or clamping onto thecannula, the type of cannula that has been docked, and any scenariosthat could indicate cannula release. Each of these states can then becommunicated to the user using visual, audio, or other forms of feedbackon the robotic arm, as well as via any form of similar feedback on thesurgeon bridge. Representatively, when the robotic arm is ready to bedocked to a cannula, the latch, lever or actuator may be pressed to openthe attachment device and allow it to sit on the lockout that holds thelatch open. This movement of the latch actuator may be sensed by two,redundant latch position encoders and enable a gravity compensatedactive back (GCAB) driving mechanism associated with the surgicalrobotic arm for positioning of the arm to the docking position. Once thearm is positioned and the cannula is pushed into the distal block, thelockout will be disengaged allowing the latch to close and secure thecannula to the arm. At this point the latch position encoders may sensethat the attachment device has been closed and has passed a mechanicalover-center point, which deactivates GCAB and holds the arm in thatdocked position. The signal from these encoders is actively monitoredand if the lever or latch is accidentally depressed after a cannula hasbeen docked, the state machine will transition to an error state thatshould stop the procedure and notify the user.

In another aspect, the invention provides an over center latchingmechanism, structural alignment features as part of the attachmentdevice and/or cannula to ensure proper attachment between the attachmentdevice and the cannula and/or a cannula sterile adapter having bothflexible and rigid portions to ensure proper attachment and/or alignmentbetween the cannula and attachment device. Representatively, theattachment device may include a lever, actuator or the like with an overcenter configuration that ensures that the lever (or latch) cannot beback driven to an open position by forces applied to the cannula. Onceover center, the latch will increasingly force itself closed with anyincreasing load applied to the cannula. This aspect ensures that thecannula is held securely and reliably to the robotic arm during surgery.In another aspect, the cannula and attachment device interfaces may havealignment features that mate with one another to ensure proper alignmentand attachment of the cannula to the attachment device. In still furtheraspects, the sterile adapter that sits between the cannula and theattachment device may have both rigid and structural features that allowthe interfacing surfaces of the cannula and attachment device alignmentfeatures to mate with one another and provide for a secure attachmentbetween the two structures.

In another aspect, the attachment device may include a ball bearingtrigger mechanism that reduces wear and increases reliability of theattachment device. Representatively, the lock out mechanism of theattachment device (which holds the device in the open configuration) mayinclude a trigger hook that interfaces with a ball bearing on the leveror actuator, instead of a fixed structure. This, in turn, reduces wearbetween the interfacing surfaces. In addition, the geometry of thetrigger hook may be configured to have a particular size and shape thatallows a desired amount of force to transition the lock out mechanismbetween the lock out open position in which it engages the bearing andthe closed position in which the hook disengages the bearing.

In another aspect, the attachment device may have an adjustmentmechanism for adjusting the docking force required to transition theattachment device between the lock out open position (e.g., the lock outmechanism is engaged with the ball bearing) and closed positions (e.g.,the lock out mechanism disengages the ball bearing). For example, theattachment device may include a set screw positioned between the lockout mechanism hook and the bearing that biases the lockout towardsdisengagement when tightened. As the lockout adjustment set screw istightened, it presses against the bearing and shifts the lockout suchthat it has less engagement with the lockout bearing than before it wastightened. By shortening the distance that the lockout has to travel tobecome disengaged, the force is able to be lowered. The opposite can beachieved by loosening the adjustment screw and allowing more engagement.In some aspects, the adjustment mechanism is operable to adjust theforce required to disengage the lock out bearing to within a range offrom 3 pounds of force to 14 pounds of force.

Representatively, on one aspect, an apparatus for attaching a cannula toa robotic surgical system includes a first clamp component configured totransition between an open position and a closed position; a secondclamp component spaced from the first clamp component, the first andsecond clamp components defining a region configured to receive aportion of the cannula and configured to retain the portion of thecannula in the region when the first clamp component is in the closedposition; and a locking component configured to lock the first clampcomponent in the open position and allow the first clamp component toautomatically transition to the closed position based on a position ofthe portion of the cannula within the region. In one aspect, the lockingcomponent locks the first component in the open position when theposition of the portion of the cannula is misaligned within the region.In another aspect, the first clamp component automatically transitionsfrom the open position to the closed position when the position of theportion of the cannula is aligned within the region. In another aspect,the cannula contacts a portion of the locking component when it isaligned within the region and causes the locking component to disengagewith the first clamp component allowing the first clamp component totransition from the open position to the closed position. Still further,the locking component may mechanically detect whether the portion of thecannula is in an aligned or misaligned position within the region. Theapparatus may further include one or more processors configured tosignal to the robotic surgical system that a user is in the process ofattaching the cannula to the robotic surgical system when the firstclamp component is in the open position and the portion of the cannulais within the region.

In another aspect, a system for attaching a cannula to a roboticsurgical system, the system includes a clamp assembly having an openposition configured to receive a cannula, and a closed positionconfigured to attach the cannula to a robotic arm of the roboticsurgical system; a lock assembly coupled to the clamp assembly, the lockassembly configured to lock the clamp assembly in the open position andallow the clamp assembly to automatically transition to the closedposition based on a position of the cannula within the clamp assembly;and one or more processors configured to signal to the robotic surgicalsystem that the clamp assembly is in a docking mode when the clampassembly is locked in the open position or a clamping mode when theclamp assembly is locked in the closed position. In some aspect, in thedocking mode, the clamp assembly remains locked in the open positionuntil the detected position of the cannula is a position suitable forattachment to the surgical robotic system. In the clamping mode, thesurgical robotic system may notify a user that the cannula is attachedto the robotic surgical system. In another aspect, the lock assembly maylock the clamp assembly in the open position when the detected positionof the cannula is misaligned. In some aspects, the lock assembly isfurther configured to transition the clamp assembly from the openposition to the closed position when the detected position of thecannula is aligned. The lock assembly may include a lever coupled to alock out mechanism that locks or unlocks the clamping assembly based onthe position of the cannula.

In another aspect, a system for detecting an attachment of a cannula toa robotic surgical system may include a clamp assembly having an openposition configured to receive a cannula, and a closed positionconfigured to attach the cannula to a robotic arm of the roboticsurgical system; a sensor assembly operable to sense a characteristic ofthe clamp assembly; and one or more processors configured to determine astate of the clamp assembly based on the characteristic sensed by theone or more sensors, and provide feedback to the user relating to thestate of the clamp assembly. The clamp assembly may include a lever thatis operable to transition the clamp assembly between the open positionand the closed position, and the sensor assembly comprises a positionsensor coupled to the lever. In some aspects, the characteristic sensedby the position sensor is an angle of the lever. In some aspects, thestate of the clamp assembly determined by the one or more processors isthe open position or the closed position, and is determined based on theangle of the lever. In some aspects, a visual feedback mechanism or anaudio feedback mechanism that indicates to the user the state of theclamp assembly is (1) the cannula is present within the clamp assemblyor (2) the cannula has been released from the clamp assembly may beprovided.

In another aspect, a system for detecting an attachment of a cannula toa robotic surgical system includes a clamp assembly having an openposition configured to receive a cannula, and a closed positionconfigured to attach the cannula to a robotic arm of the roboticsurgical system; a sensor assembly operable to sense a characteristicthe cannula when received by the clamp assembly; and one or moreprocessors configured to determine a state of the cannula based on thecharacteristic sensed by the one or more sensors, and provide feedbackto the user relating to the state of the cannula. In some aspects, theposition sensor is a magnetic encoder and the cannula comprises a magnetthat is sensed by the magnetic encoder to sense the characteristic ifthe cannula. In another aspect, the characteristic of the cannulacomprises a presence of the cannula within a receiving portion of theclamp assembly. In some aspects, the state of the cannula determinedbased on the characteristic is that the cannula is properly attached tothe robotic arm or that the cannula attachment to the robotic arm isreleased. In another aspect, the characteristic of the cannula is a typeof cannula within the receiving portion of the clamp assembly. In someaspects, the type of cannula within the receiving portion of the clampassembly is determined based on an angle of the magnet coupled to thecannula. In another aspect, the system includes a visual feedbackmechanism or an audio feedback mechanism.

In another aspect, a method for controlling an attachment of a cannulato a robotic surgical system may include a clamp assembly configured toattach a cannula to a robotic surgical system, the clamp assemblyoperable to transition between an open position configured to receivethe cannula and a closed position to attach the cannula to the roboticsurgical system; a sensor assembly operable to detect whether the clampassembly is in the open position or the closed position, or a presenceof the cannula received by the clamp assembly; and one or moreprocessors configured to control an attachment of the cannula to therobotic surgical system based on the detection by the sensor assembly.In some aspects, when the sensor assembly detects the clamp assembly isin the open position, the one or more processors cause the surgicalrobotic system to disengage a braking assembly associated with asurgical robotic arm coupled to the clamping assembly; engage a gravitycompensated active back driving mechanism associated with the surgicalrobotic arm to allow for positioning of the cannula within the clampingassembly. In another aspect, when the sensor assembly detects atransition of the clamp assembly to the closed position, the one or moreprocessors cause the surgical robotic system to engage a brakingassembly associated with a surgical robotic arm; and disengage thegravity compensated active back driving mechanism associated with thesurgical robotic arm so that a current position of the cannula relativeto the clamping assembly is maintained. In another aspect, when thesensor assembly detects a transition of the clamp assembly to the closedposition, the one or more processors cause the surgical robotic systemto engage a braking assembly associated with a surgical robotic armcoupled to the cannula; and disengage the gravity compensated activeback driving mechanism associated with the surgical robotic arm. Inanother aspect, the sensor assembly further detects the cannula ispresent within the clamp assembly, and upon detecting the cannula ispresent, the one or more processors cause the surgical robotic system tonotify a user that the cannula is attached to the surgical roboticsystem. In another aspect, the sensor assembly further detects thecannula is present within the clamp assembly, and upon detecting thecannula is present, the one or more processors cause the surgicalrobotic system to determine a type of cannula; and notify a user of thetype of cannula. In another aspect, when the sensor assembly detects atransition of the clamp assembly to the open position, detects thecannula is not present within the clamp assembly, or does not sense acannula identifier (ID) the one or more processors cause the surgicalrobotic system to engage a braking assembly associated with a surgicalrobotic arm; and notify a user that the surgical robotic system is readyfor cannula attachment.

In another aspect, an apparatus for attachment of a cannula to a roboticsurgical system may include a clamp operable to transition between anopen position configured to receive a cannula and a closed position toattach the cannula to a robotic surgical system; an actuator operable totransition the clamp between the open position and the closed position;and a linking member pivotally coupled to the camp at a first pivotpoint and the actuator at a second pivot point, and wherein in theclosed position, the second pivot point is over center relative to thefirst pivot point. In some aspects, in the closed position, the secondpivot point is over center relative to the first pivot point by an angleof one degree or less. In another aspect, having the second pivot pointover center relative to the first pivot point causes the clamp toincreasingly force itself to the closed position with any increasingload applied to the cannula attached to the robotic surgical system. Inanother aspect, having the second pivot point over center relative tothe first pivot point prevents the clamp from transitioning to the openposition when a force is applied to the cannula attached to the roboticsurgical system. In another aspect, the clamp may include a first endrotatably coupled to a base member at a third pivot point and a secondend that rotates to a forward position to attach the cannula to therobotic surgical system. The second end may include a cannula matingfeature configured to reinforce the attachment of the cannula to therobotic surgical system. In some aspects, the actuator is coupled to thebase member at a fourth pivot point to form a four bar linkagemechanism. In some aspects, the actuator comprises a first endconfigured to allow a user to manually cause the actuator to transitionthe clamp to the open position and a second end proximate to a lockoutmechanism, wherein the lock out mechanism engages with the actuator tolock the clamp in the open position, and disengages with the actuator toallow the clamp to transition to the closed position upon beingcontacted by the cannula. In another aspect, the apparatus may furtherinclude a base member having a cannula receiving chamber within whichthe cannula is positioned when attached to the robotic surgical systemby the clamp, and wherein the receiving chamber comprises a cannulamating feature to guide the cannula into the receiving chamber andprevent misalignment of the cannula.

In another aspect, a sterile adapter for attachment of a cannula to arobotic surgical system includes a rigid barrier portion having acannula interface defining an opening dimensioned to receive a cannulalug, a first cannula interface structure extending from the cannulainterface, and a second cannula interface, the first cannula interfaceand the second cannula interface are dimensioned to interface withalignment structures of a cannula lug; and a flexible barrier portionmolded to the rigid barrier portion, the flexible barrier portiondefining a cavity around the opening of the rigid barrier portion thatis dimensioned to receive a cannula lug inserted therein, the cavityhaving a first side defined by the first cannula interface structure anda second side along which the second cannula interface structure isposition, and wherein the second cannula interface structure is entirelysurrounded by the flexible barrier portion. In some aspects, the cannulainterface includes a plate having an arm side that faces a roboticsurgical arm of the robotic surgical system and a cannula side thatfaces the cannula lug, and the first cannula interface structure extendsfrom the arm side in a direction of the robotic surgical arm. Theflexible barrier portion may be molded to the arm side of the plate anddefines at least three sides of the cavity. In some aspects, the firstcannula interface structure may include a keel shaped structuredimensioned to interface with a complimentary recessed region of thecannula lug. In some aspects, the rigid clamp interface portion mayinclude a plate molded to the second side. In some aspects, an angle ofthe plate is modifiable to an angle of the alignment structures of thecannula lug. In some aspects, a retention bump is coupled to the secondside of the flexible barrier portion, and the retention bump dimensionedto retain the cannula sterile adapter within a clamping assembly duringinsertion and removal of the cannula lug within the clamping assembly.In addition, a mating datum may be coupled to a third side of theflexible barrier portion and configured to maintain an alignment betweenthe cannula lug inserted therein and an axis of an associated tool. Insome aspects, the rigid barrier portion is formed by a plastic material.In some aspects, the flexible barrier portion is formed by a flexibleelastomeric material that is overmolded to the rigid barrier portion. Insome aspects, the flexible barrier portion includes a thermoplasticpolyurethane.

In another aspect, an apparatus for attaching a cannula to a roboticsurgical system may include a clamp assembly configured to attach acannula to a robotic surgical system, the clamp assembly comprising anactuator coupled to a clamp to transition the clamp between an openposition configured to receive the cannula and a closed position toattach the cannula to the robotic surgical system; and a lock outassembly coupled to the clamp assembly to control the transition of theclamp, the lock out assembly having a hook that is dimensioned to engagea bearing coupled to the actuator when the clamp is in the open positionand disengage the bearing to allow the clamp to automatically transitionto the closed position. In some aspects, the hook may include a tip thatextends beyond a tangent point of the bearing to engage the bearing, andwhen the tip is aligned with the tangent point, the hook disengages thebearing to allow the clamp to transition to the closed position. In someaspects, aligning the tip with the tangent point causes a rotation ofthe bearing that allows the hook to disengage the bearing. In someaspects, the hook is coupled to a spring to bias the hook to engage thebearing. In some aspects, the engagement or disengagement between thehook and the bearing provides an audible feedback or haptic feedbackthat notifies the user of an engagement state of the lock out assembly.The lock out assembly may be disengaged from the bearing when contactedby a cannula inserted into the clamp assembly. The apparatus may furtherinclude an adjustment mechanism operable to adjust a force required tocause the hook to engage or disengage the bearing. The adjustmentmechanism may include a set screw that is adjustable between a firstposition that increases a spacing between the hook and the bearing and asecond position that decreases the spacing between the hook and thebearing. In some aspects, in the first position, a force required tocause the hook to disengage the bearing is reduced. In some aspects, inthe second position, a force required to cause the hook to disengage thebearing is increased.

In another aspect, an apparatus for attaching a cannula to a roboticsurgical system may include a clamp operable to transition between anopen position configured to receive the cannula and a closed position toattach the cannula to the robotic surgical system; a locking assemblycoupled to the clamp assembly to hold the clamp in the open position andrelease the clamp to the closed position upon application of a force bya cannula, the locking assembly having a lock out hook that engages alock out bearing of the clamp in the open position and disengages thelock out bearing to release the clamp to the closed position; and anadjustment member operable to adjust a force required to disengage thelock out bearing. In some aspects, the lock out hook is biased towardengagement of the lock out bearing by a spring. In another aspect, theadjustment member shifts a position of the lock out hook away from thelock out bearing to reduce the force required to disengage the lock outbearing. In another aspect, the adjustment member shifts a position ofthe lock out hook toward the lock out bearing to increase the forcerequired to disengage the lock out bearing. In some aspects, theadjustment member includes a set screw extending through the lock outhook to an interface between the lock out hook and the lock out bearing.In one aspect, tightening the set screw shifts the position of the lockout hook away from the lock out bearing. In another aspect, looseningthe set screw shifts the position of the lock out hook toward the lockout bearing. In some aspects, the lock out bearing is a ball bearing. Inanother aspect, the clamp may include an actuator that is coupled to afirst clamp component of the clamp and is operable to move the firstclamp component between the open position and the closed position, andthe ball bearing is coupled to the actuator.

The above summary does not include an exhaustive list of all aspects ofthe present invention. It is contemplated that the invention includesall systems and methods that can be practiced from all suitablecombinations of the various aspects summarized above, as well as thosedisclosed in the Detailed Description below and particularly pointed outin the claims filed with the application. Such combinations haveparticular advantages not specifically recited in the above summary.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overview schematic of an operating room arrangement with asurgical robotic system.

FIG. 2 is a perspective view of a portion of a robotic arm according toone aspect of the disclosure.

FIG. 3 is a schematic perspective view of an attachment device of therobotic arm of FIG. 2.

FIG. 4A is a cross-sectional side view of the attachment device of therobotic arm of FIG. 2 in an open position.

FIG. 4B is a cross-sectional side view of the attachment device of therobotic arm of FIG. 2 in a closed position.

FIG. 5 is a process flow diagram of a method for providing user feedbackrelating to the attachment device of the robotic arm of FIG. 2.

FIG. 6 is a cross-sectional side view of a sensor assembly associatedwith the attachment device of FIGS. 4A-4B.

FIG. 7 is a process flow diagram of a method for detecting docking usingthe attachment device of the robotic arm of FIG. 2.

FIG. 8A is a cross-sectional side view of another aspect of theattachment device of FIGS. 4A-4B in the open position.

FIG. 8B is a cross-sectional side view of another aspect of theattachment device of FIGS. 4B-4B.

FIG. 9A is a cross-sectional side view of another aspect of theattachment device of FIGS. 4A-4B.

FIG. 9B is a magnified cross-sectional side view of a portion of theattachment device of FIG. 9A.

FIG. 9C is a cross-sectional side view of another aspect of theattachment device of FIGS. 4A-4B.

FIG. 9D is a cross-sectional side view of another aspect of theattachment device of FIGS. 4B-4B.

FIG. 10A is a cross-sectional side view of another aspect of theattachment device of FIGS. 4A-4B.

FIG. 10B is a bottom side perspective view of a portion of theattachment device of FIGS. 4A-4B.

FIG. 10C is a top side perspective view of a portion of the attachmentdevice of FIGS. 4A-4B.

FIG. 11A is a bottom perspective view of a sterile adapter of theattachment device of FIGS. 4A-4B.

FIG. 11B is a top perspective view of the sterile adapter of FIG. 11A.

FIG. 11C is a cross-sectional side view of the sterile adapter of FIG.11A with the attachment device in an open position.

FIG. 11D is a cross-sectional side view of the sterile adapter of FIG.11A with the attachment device in the closed position.

FIG. 12 is a block diagram of a computer portion of a user console for asurgical robotic system including a robotic arm and attachmentmechanism, in accordance with an embodiment.

DETAILED DESCRIPTION

In various embodiments, description is made with reference to thefigures. However, certain embodiments may be practiced without one ormore of these specific details, or in combination with other knownmethods and configurations. In the following description, numerousspecific details are set forth, such as specific configurations,dimensions, and processes, in order to provide a thorough understandingof the embodiments. In other instances, well-known processes andmanufacturing techniques have not been described in particular detail inorder to not unnecessarily obscure the description. Reference throughoutthis specification to “one embodiment,” “an embodiment,” or the like,means that a particular feature, structure, configuration, orcharacteristic described is included in at least one embodiment. Thus,the appearance of the phrase “one embodiment,” “an embodiment,” or thelike, in various places throughout this specification are notnecessarily referring to the same embodiment. Furthermore, theparticular features, structures, configurations, or characteristics maybe combined in any suitable manner in one or more embodiments.

In addition, the terminology used herein is for the purpose ofdescribing particular aspects only and is not intended to be limiting ofthe invention. Spatially relative terms, such as “beneath”, “below”,“lower”, “above”, “upper”, and the like may be used herein for ease ofdescription to describe one element's or feature's relationship toanother element(s) or feature(s) as illustrated in the figures. It willbe understood that the spatially relative terms are intended toencompass different orientations of the device in use or operation inaddition to the orientation depicted in the figures. For example, if thedevice in the figures is turned over, elements described as “below” or“beneath” other elements or features would then be oriented “above” theother elements or features. Thus, the exemplary term “below” canencompass both an orientation of above and below. The device may beotherwise oriented (e.g., rotated 90 degrees or at other orientations)and the spatially relative descriptors used herein interpretedaccordingly.

As used herein, the singular forms “a”, “an”, and “the” are intended toinclude the plural forms as well, unless the context indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising” specify the presence of stated features, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, steps, operations,elements, components, and/or groups thereof.

The terms “or” and “and/or” as used herein are to be interpreted asinclusive or meaning any one or any combination. Therefore, “A, B or C”or “A, B and/or C” mean “any of the following: A; B; C; A and B; A andC; B and C; A, B and C.” An exception to this definition will occur onlywhen a combination of elements, functions, steps or acts are in some wayinherently mutually exclusive.

Moreover, the use of relative terms throughout the description maydenote a relative position or direction. For example, “distal” mayindicate a first direction away from a reference point, e.g., away froma user. Similarly, “proximal” may indicate a location in a seconddirection opposite to the first direction, e.g., toward the user. Suchterms are provided to establish relative frames of reference, however,and are not intended to limit the use or orientation of any particularsurgical robotic component to a specific configuration described in thevarious embodiments below.

Referring to FIG. 1, this is a pictorial view of an example surgicalrobotic system 100 in an operating arena. The surgical robotic system100 includes a user console 102, a control tower 103, and one or moresurgical robots 120, including robotic arms 104 at a surgical roboticplatform 105, e.g., an operating table, a bed, etc. The system 100 canincorporate any number of devices, tools, or accessories used to performsurgery on a patient 106. For example, the system 100 may include one ormore surgical tools 107 used to perform surgery. A surgical tool 107 maybe an end effector that is attached to a distal end of a surgical arm104, for executing a surgical procedure.

Each surgical tool 107 may be manipulated manually, robotically, orboth, during the surgery. For example, the surgical tool 107 may be atool used to enter, view, or manipulate an internal anatomy of thepatient 106. In an embodiment, the surgical tool 107 is a grasper thatcan grasp tissue of the patient. The surgical tool 107 may be controlledmanually, by a bedside operator 108; or it may be controlledrobotically, via actuated movement of the surgical robotic arm 104 towhich it is attached. The robotic arms 104 are shown as a table-mountedsystem, but in other configurations the arms 104 may be mounted in acart, ceiling or sidewall, or in another suitable structural support.

Generally, a remote operator 109, such as a surgeon or other operator,may use the user console 102 to remotely manipulate the arms 104 and/orthe attached surgical tools 107, e.g., teleoperation. Teleoperation maybe engaged or disengaged based on the user actions. It should beunderstood that “engaging” the teleoperation mode is intended to referto an operation in which, for example, a UID or foot pedal that isprevented from controlling the surgical instrument, is transitioned to amode (e.g., a teleoperation mode) in which it can now control thesurgical instrument. On the other hand, disengaging the teleoperationmode is intended to refer to an operation which occurs when the systemis in a teleoperation mode, and then transitioned to a mode(non-teleoperation mode) in which the UID or foot pedal can no longercontrol the surgical instrument. For example, teleoperation mode may bedisengaged when the system determines that a detected movement is anunintended action or movement by the user or the user engages in anyother action which suggests teleoperation mode should no longer beengaged.

The user console 102 may be located in the same operating room as therest of the system 100, as shown in FIG. 1. In other environmentshowever, the user console 102 may be located in an adjacent or nearbyroom, or it may be at a remote location, e.g., in a different building,city, or country. The user console 102 may comprise a seat 110, one ormore user interface devices, for example, foot-operated controls 113 orhandheld user input devices (UID) 114, and at least one user display 115that is configured to display, for example, a view of the surgical siteinside the patient 106. In the example user console 102, the remoteoperator 109 is sitting in the seat 110 and viewing the user display 115while manipulating a foot-operated control 113 and a handheld UID 114 inorder to remotely control the arms 104 and the surgical tools 107 (thatare mounted on the distal ends of the arms 104).

In some variations, the bedside operator 108 may also operate the system100 in an “over the bed” mode, in which the bedside operator 108 (user)is now at a side of the patient 106 and is simultaneously manipulating arobotically-driven tool (end effector as attached to the arm 104), e.g.,with a handheld UID 114 held in one hand, and a manual laparoscopictool. For example, the bedside operator's left hand may be manipulatingthe handheld UID to control a robotic component, while the bedsideoperator's right hand may be manipulating a manual laparoscopic tool.Thus, in these variations, the bedside operator 108 may perform bothrobotic-assisted minimally invasive surgery and manual laparoscopicsurgery on the patient 106.

During an example procedure (surgery), the patient 106 is prepped anddraped in a sterile fashion to achieve anesthesia. Initial access to thesurgical site may be performed manually while the arms of the roboticsystem 100 are in a stowed configuration or withdrawn configuration (tofacilitate access to the surgical site). To create a port for enablingintroduction of a surgical instrument into the patient 106, a trocarassembly may be at least partially inserted into the patient through anincision or entry point in the patient (e.g., in the abdominal wall).The trocar assembly may include a cannula or trocar, an obturator,and/or a seal. In some variations, the trocar assembly can include anobturator such as a needle with a sharpened tip for penetrating througha patient's skin. The obturator may be disposed within the lumen of thecannula when being inserted into the patient 106, and then removed fromthe cannula such that a surgical instrument may be inserted through thelumen of the cannula. Once positioned within the body of the patient106, the cannula may provide a channel for accessing a body cavity orother site within the patient 106, for example, such that one or moresurgical instruments or tools can be inserted into a body cavity of thepatient 106, as described further herein. It will be understood that thecannula as described herein may be part of a trocar, and can optionallyinclude an obturator or other components.

Once access is completed, initial positioning or preparation of therobotic system 100 including its arms 104 may be performed. Next, thesurgery proceeds with the remote operator 109 at the user console 102utilising the foot-operated controls 113 and the UIDs 114 to manipulatethe various end effectors and perhaps an imaging system, to perform thesurgery. Manual assistance may also be provided at the procedure bed ortable, by sterile-gowned bedside personnel, e.g., the bedside operator108 who may perform tasks such as retracting tissues, performing manualrepositioning, and tool exchange upon one or more of the robotic arms104. Non-sterile personnel may also be present to assist the remoteoperator 109 at the user console 102. When the procedure or surgery iscompleted, the system 100 and the user console 102 may be configured orset in a state to facilitate post-operative procedures such as cleaningor sterilisation and healthcare record entry or printout via the userconsole 102.

In one embodiment, the remote operator 109 holds and moves the UID 114to provide an input command to move a robot arm actuator 117 in therobotic system 100. The UID 114 may be communicatively coupled to therest of the robotic system 100, e.g., via a console computer system 116.Representatively, in some embodiments, UID 114 may be a portablehandheld user input device or controller that is ungrounded with respectto another component of the surgical robotic system. For example, UID114 may be ungrounded while either tethered or untethered from the userconsole. The term “ungrounded” is intended to refer to implementationswhere, for example, both UIDs are neither mechanically nor kinematicallyconstrained with respect to the user console. For example, a user mayhold a UID 114 in a hand and move freely to any possible position andorientation within space only limited by, for example, a trackingmechanism of the user console. The UID 114 can generate spatial statesignals corresponding to movement of the UID 114, e.g. position andorientation of the handheld housing of the UID, and the spatial statesignals may be input signals to control a motion of the robot armactuator 117. The robotic system 100 may use control signals derivedfrom the spatial state signals, to control proportional motion of theactuator 117. In one embodiment, a console processor of the consolecomputer system 116 receives the spatial state signals and generates thecorresponding control signals. Based on these control signals, whichcontrol how the actuator 117 is energized to move a segment or link ofthe arm 104, the movement of a corresponding surgical tool that isattached to the arm may mimic the movement of the UID 114. Similarly,interaction between the remote operator 109 and the UID 114 can generatefor example a grip control signal that causes a jaw of a grasper of thesurgical tool 107 to close and grip the tissue of patient 106.

The surgical robotic system 100 may include several UIDs 114, whererespective control signals are generated for each UID that control theactuators and the surgical tool (end effector) of a respective arm 104.For example, the remote operator 109 may move a first UID 114 to controlthe motion of an actuator 117 that is in a left robotic arm, where theactuator responds by moving linkages, gears, etc., in that arm 104.Similarly, movement of a second UID 114 by the remote operator 109controls the motion of another actuator 117, which in turn moves otherlinkages, gears, etc., of the robotic system 100. The robotic system 100may include a right arm 104 that is secured to the bed or table to theright side of the patient, and a left arm 104 that is at the left sideof the patient. An actuator 117 may include one or more motors that arecontrolled so that they drive the rotation of a joint of the arm 104, tofor example change, relative to the patient, an orientation of anendoscope or a grasper of the surgical tool 107 that is attached to thatarm. Motion of several actuators 117 in the same arm 104 can becontrolled by the spatial state signals generated from a particular UID114. The UIDs 114 can also control motion of respective surgical toolgraspers. For example, each UID 114 can generate a respective gripsignal to control motion of an actuator, e.g., a linear actuator, thatopens or closes jaws of the grasper at a distal end of surgical tool 107to grip tissue within patient 106. When the user is finished controllingthe surgical tools with the UIDs 114, the user may dock (i.e., store)the UIDs 114 with docking stations or UID holders located on the console102. For example, the console 102 may include docking stations 130 ateach of the left and right arm rests of the chair 110. To dock the UIDs114, the user may move the left UID 114 to the left docking station 130and the right UID 114 to the right docking station 130, and place eachUID in their respective docking station holder.

In some aspects, the communication between the platform 105 and the userconsole 102 may be through a control tower 103, which may translate usercommands that are received from the user console 102 (and moreparticularly from the console computer system 116) into robotic controlcommands that are transmitted to the arms 104 on the robotic platform105. The control tower 103 may also transmit status and feedback fromthe platform 105 back to the user console 102. The communicationconnections between the robotic platform 105, the user console 102, andthe control tower 103 may be via wired and/or wireless links, using anysuitable ones of a variety of data communication protocols. Any wiredconnections may be optionally built into the floor and/or walls orceiling of the operating room. The robotic system 100 may provide videooutput to one or more displays, including displays within the operatingroom as well as remote displays that are accessible via the Internet orother networks. The video output or feed may also be encrypted to ensureprivacy and all or portions of the video output may be saved to a serveror electronic healthcare record system. It will be appreciated that theoperating room scene in FIG. 1 is illustrative and may not accuratelyrepresent certain medical practices.

Turning to FIG. 2, a portion of a robotic arm 200 (e.g., robotic arm104) is illustrated according to one aspect of the disclosure. Therobotic arm 200 and associated components described herein can form asurgical robotic system according to an embodiment of the disclosure.The robotic arm 200 can be incorporated into the surgical robotic system100 described in reference to FIG. 1, or can form a portion of adifferent system. While a single robotic arm 200 is illustrated, it willbe understood that the robotic arm 200 may include additional armportions or may be a component of a multi-arm apparatus withoutdeparting from the disclosure.

The robotic arm 200 may include a plurality of links (e.g., links202A-202E) and a plurality of joint modules (e.g., joints 204A-204E) foractuating the plurality of links relative to one another. The jointmodules can include various joint types, such as a pitch joint or a rolljoint, any of which can be actuated manually or by the robotic armactuators (e.g., actuators 117), and any of which may substantiallyconstrain the movement of the adjacent links around certain axesrelative to others. As also shown, a tool drive 206 is attached to thedistal end of the robotic arm 200. As described herein, the tool drive206 can be configured with an attachment device or docking interface 212to receive an attachment portion (e.g., a mating interface or cannulalug) of a cannula and attach the cannula to the robotic arm such thatone or more surgical instruments (e.g., endoscopes, staplers, etc.) canbe guided through a lumen of the cannula of the trocar. For example, thetool drive 206 may include an elongated base (or “stage”) 208 and a toolcarriage 210, which is slidingly engaged with the elongated base orstage 208. The stage 208 may be configured to couple to the distal endof a robotic arm 200 such that articulation of the robotic arm 200positions and/or orients the tool drive 206 in space. The tool carriage210 may be configured to receive a tool for extending through theassociated cannula of a trocar. Additionally, the tool carriage 210 mayactuate a set of articulated movements through a cable system or wiresmanipulated and controlled by actuated drives (the terms “cable” and“wire” are used interchangeably throughout this application). The toolcarriage 210 may include different configurations of actuated drives,such as a mechanical transmission. The plurality of the joint modules204A-204E of the robotic arm 200 can be actuated to position and orientthe tool drive 206 for robotic surgeries.

Referring additionally to FIG. 3, FIG. 3 illustrates a magnifiedperspective view of an attachment device associated with a robotic arm(e.g., docking interface 212 of robotic arm 200). As will be describedin more detail in reference to FIG. 4A-4B, a cannula can be coupled tothe tool drive 206 or another component of the surgical robotic system100 at the attachment device or docking interface 212 located at adistal block of the elongated base 208. The attachment device or dockinginterface 212 is configured to receive a portion of the cannula (e.g.,cannula lug). The attached device or docking interface 212 may bereferred to interchangeably herein as a cannula or trocar dockinginterface, attachment device, or mounting device. The docking interface212 can provide a reliable and quick way to attach the cannula to thesurgical robotic system 100.

The attachment device or docking interface 212 can define a chamber 302that is accessible through a mouth or frontal opening 304 of the dockinginterface 212 and which can include first and second clamp components306, 308 (e.g., arms, plates, levers, members) arranged about a receiver310 that defines a receiving space 312 for receiving a portion of thetrocar or cannula (e.g., a cannula lug in a proximal portion of thecannula). At least one of the clamp components 306, 308 may be pivotablebetween an open position and a closed position such that an attachmentportion of the cannula (e.g., cannula lug) can be inserted into thereceiving space 312 between the clamp components 306, 308 so that aportion of the cannula is held in place at least partially by the firstand second clamp components 306, 308.

In one variation, the attachment device or docking interface 212 mayinclude an over-center mechanism such as an actuator, latch or lever 314or other suitable locking component that mechanically cooperates withthe clamp component 306, for example, through a pin and slot arrangementor through another pivotable or movable connection, between the open andclosed positions. The lever 314 may be coupled to, or otherwise assistwith locking the device in an open or closed position, and may thereforealso be referred to herein as a locking assembly or component, or beconsidered part of a locking assembly or component. The actuator orlever 314 can be movable between a forward, locked position (e.g., alocked over-center position) and a rearward, unlocked position. When theactuator or lever 314 is moved toward the locked position, the lever 314may urge the clamp component 306 downwardly toward the receiving space312 and lock the clamp component 306 in the closed position such that aportion of the cannula (e.g., a cannula lug) is securely held betweenthe first and second clamp components 306, 308. In some variations,second clamp component 308 can be stationary or can be fixed. In onevariation, the actuator or lever 314 can be controlled and/or drivenmanually or automated, or a combination of manually and automated.Representatively, in some aspects, the attachment device may include afully mechanical locking assembly that locks the clamp in the openposition (e.g., a lock-out position) and then automatically transitionsto a closed position (e.g. locked position) upon detecting that thecannula is inserted into the clamp in the proper position. The specificconfiguration of the locking component(s) and its operation will bedescribed in more detail in reference to FIG. 4A-4B.

In some variations, the attachment device or docking interface 212 mayalso provide a sterile barrier between sterile components such as thecannula and non-sterile components such as the first and second clampcomponents 306, 308 (or other non-sterile components of the surgicalsystem). The sterile barrier may be provided, for example, by a sterileadapter interposed between the cannula and the first and second clampcomponents 306, 308 (as described in more detail in reference to FIG.11A-11D)

In some aspects, the attachment device or docking interface 212 may alsoinclude a sensor system 316. The sensor system 316 may be used todetect, for example, a characteristic of the cannula positioned withinthe docking interface 212 as will be described in more detail inreference to FIGS. 6-7 and/or FIGS. 10A-10B. The sensor system 316 mayinclude a motherboard or first sensor board 318 at a first location ofthe docking interface 212 and a daughterboard or second sensor board 320at second location of the docking interface 212 and in electricalcommunication with the first sensor board 318 via a cable 322 or otherelectrically conductive connection. In one variation, communicationbetween the sensor boards 318, 320 can employ a multi-slave andmulti-master inter-integrated communication computer bus. One or both ofthe sensor boards 318, 320 can include a microprocessor or otherassociated processor, for example, to control and/or read the sensors ofthe sensor boards 318, 320 and to facilitate communication between thesensor boards 318, 320, e.g., to enable temporal synchronization betweenthe sensor boards 318, 320. As shown, the first sensor board 318 and thesecond sensor board 320 are positioned spaced apart from but parallel toeach other, e.g., facing each other, on opposite lateral sides of thechamber 302 of the docking interface 212. The first sensor board 318includes may include a first plurality of sensors 324 and the secondsensor board 320 may include a second plurality of sensors 326. Forexample, the sensors 324, 326 may be embedded in or otherwise coupled tothe robotic arm 200 or the tool drive 212. Each of the plurality ofsensors 324, 326 may be arranged such that at least one sensor 324, 326is disposed rearward, e.g., at a depth measured from the frontal opening304 of the docking interface 212, with respect to another respectivesensor 324, 326. While the sensors 324, 326 have been described in agrid-like configuration of rows, it will be understood that one or bothof the pluralities of sensors 324, 326 can have a different arrangementwithout departing from the disclosure.

As described further herein, the sensors 324, 326 may be operable tosense or measure a magnetic field associated with the cannula insertedtherein, and produce respective corresponding electrical signals. Inthis regard, the sensors 324, 326 can be configured as magnetometers,e.g., sensors that receive at least a portion of a magnetic field as aninput and produce an output electrical signal corresponding to astrength or other characteristic of the magnetic field, and such thatthe sensors 324, 326 can be transducers. Any of the sensors 324, 326 canbe configured to receive a different physical input and produce acorresponding electrical signal, for example, inertial measurementunits, accelerometers, etc. In this regard, the sensors 324, 326 producean output electrical signal that can be electrically communicated to,for example, a processor or controller that is incorporated into thecontrol tower to provide force or velocity commands to direct a movementof the robotic arm (e.g., robotic arm 200) via the robotic arm actuators(e.g., actuators 117), as described further herein. It will beunderstood that a processor can be incorporated into additional oralternative portions of the surgical robotic system 100, and that thesensor system 316 can be in electrical communication with one or moredifferent processors. For example, a switch 328 or other control ismounted on or near the docking interface 212, for example, behind theactuator or lever 314 at a position such that the actuator or lever 314can be urged into contact with the switch 328, as described furtherherein. The switch 328 can be in electrical communication with theprocessor in the control tower to signal the processor to energize oractivate one or both of the sensor boards 318, 320 to activate thesensor system 316 to sense or measure magnetic fields, and to effectguidance of the robotic arm toward the cannula according to analgorithm, as described further herein. In one variation, the sensorsystem 316 can be activated by the processor prior to or independentlyof the action of the switch 328, and the switch 328 can be used tosignal the processor to begin calculations based on the signals receivedfrom the sensor system 316 to determine the estimated pose of thecannula and then affect guidance of the robotic arm 200 and its coupledtool drive 206. The switch 328 can be have one of several differentconfigurations, e.g., a mechanical button and mechanical switchcombination may be preferred but another form of tactile interface or atouchscreen is also possible, that can be activated by a user.

While the sensor boards 318, 320 have been generally described asrespective first and second printed circuit boards (PCBs) including therespective sensors 324, 326 embedded therein or thereon, it will beunderstood that the sensor system 316 can be provided in a differentarrangement, for example, as discrete components, without departing fromthe disclosure. Additionally, it will be understood that any of thecomponents described herein can be in communication via wired and/orwireless links, using any suitable ones of a variety of datacommunication protocols.

Aspects of the attachment device or docking interface, and itsoperation, will now be described in more detail in reference to FIGS.4A-4B. Representatively, as can be seen from FIG. 4A-4B, the attachmentdevice or docking interface 212 may include first and second clampcomponents 306, 308 which define an opening 304 (e.g., receiving spaceor chamber) for receiving a cannula 404. The latch, actuator or lever314 for transitioning the first and second clamp components 306, 308between the open position (allowing for insertion of cannula 300 betweenclamp components 306, 308) and closed position (locking or clamping thecannula 300 between clamp components 306, 308) is also provided.Representatively, the first clamp component 306 may be moveable orpivotable about a clamp pivot point 402 by the lever 314 between an openposition, such as is shown in FIG. 4A, and a closed position, such as isshown in FIG. 4B. In some aspects, the second clamp component 308 may befixed or stationary. In other variations, the second clamp component 308may be pivotable similar to the first clamp component. The second clampcomponent 308 may be spaced from the first clamp component 306 to formthe opening 304 configured to receive a portion of the cannula 404 suchas, for example, an attachment portion or cannula lug 406 of the cannula404.

The two clamp components 306, 308 may be supported on a supportcomponent 420 such as, for example, a plate, bar, beam, or othersuitable surface of a tool driver in a robotic surgical system. Thefirst clamp component 306 may be supported on the support component 420at a first location via the first pivot point 402 (e.g., pin joint,hinge, etc.), and the second clamp component 308 may be supported on thesupport component 420 at a second location spaced from the first clampcomponent 306. In some variations, the first clamp component 306 can beattached to a pivoting structure that allows the first clamp component306 to rotate about the pivot point 402, and the pivoting structure canbe attached to the support component 420. In such variations, the firstclamp component 230 can be attached to the pivoting structure via afastener (e.g., bolt, nail, screw, pin, etc.) or an adhesive (e.g.,epoxies, polyurethanes, polyimides, etc.), and/or via other fasteningtechniques including, for example, crimping, welding, brazing, etc. Inother variations, the first clamp component 306 can be integrally formedwith a pivoting structure such as, for example, a living hinge. In somevariations, the second clamp component 308 can be directly attached tothe support component 420 via a fastener (e.g., bolt, nail, screw, pin,etc.), an adhesive (e.g., epoxies, polyurethanes, polyimide s, etc.),and/or other fastening technique (e.g., crimping, welding, brazing,etc.). In other variations, the second clamp component 308 can beintegrally formed with the support component 420. In some variations,the two clamp components 306, 308 can be formed of a plastic, a metal,or a composite material. In some variations, the two clamp components306, 308 can be formed via machining, molding, or other manufacturingtechniques. Although the variation shown generally depict two opposingclamp components, it should be understood that in other variations, theattachment device may include more than two clamp components.

In some aspects, the two clamp components 306, 308 may be non-sterileand the cannula 404 may be sterile. Thus, a sterile adapter 450 can beprovided that separates the non-sterile clamp components 306, 308 fromthe sterile cannula 404. As depicted in FIGS. 4A-4B, a sterile adapter450 may form a sterile barrier between the non-sterile clamp components306, 308 and the sterile cannula 404. The sterile adapter 404 can be acover that has an opening 452 for receiving the attachment portion 406of the cannula 404 such that, the attachment portion 406, when receivedin the sterile adapter 450, is covered or surrounded by the sterileadapter 450. The sterile adapter 450 may be sufficiently flexible incertain portions such that it can deform (e.g., receive the attachmentportion 406 when the attachment portion 406 is inserted through theopening) but have sufficient stiffness in other portions such that itretains a non-deformed or resting shape that generally corresponds to ashape of the attachment portion 406 of the cannula 404. The particularconfiguration of the sterile adapter 450, including both flexible andrigid portions, will be described in more detail in reference to FIGS.11A-11D.

The sterile adapter 450 may be releasably mounted to the base member 420such that it can be replaced as necessary. For example, the sterileadapter 450 may include an engagement mechanism that latches onto anedge or ridge of the base member 420 (or other support member coupled tothe base member 420).

As further shown, cannula 404 may have a proximal portion 416, such as,for example, a hub, fitting, connector, etc. The proximal portion 416 ofthe cannula 404 may include the attachment portion 406. The attachmentportion 406 may extend from a side of the proximal portion 416 and beconfigured for insertion within the opening 304 of the attachment deviceor docking interface 212. The cannula 404 may also have a shaft 418(partially depicted in FIGS. 4A-B) that extends from the proximalportion 416. The shaft 418 may have a lumen through which one or moresurgical instruments may be inserted. When the cannula 404 is disposedin a patient, a distal end of the shaft may be positioned within thepatient's body such as, for example, in a body cavity.

To enable a robotic surgical procedure to commence, the surgical roboticarm must be docked to the cannula. Therefore, at some point in theworkflow, the surgical staff will bring the surgical robotic arm in thesterile field to gain access to the surgical field. During thisoperation, the robotic arm (on a surgical table or on a cart) ismanually or autonomously guided toward the surgical port (incision) bythe surgical staff or the surgeon. The goal is to “dock” the surgicalarm to the cannula to establish a rigid connection and then deploysurgical tools through the access channel. Due to the delicate nature ofinteracting with the surgical incision and the confined space in theoperating room, this operation is typically carried out by one personwith one hand on the robot and one hand on the cannula. This can bechallenging because the user's ability to grab the arm is limited by thecannula position and the arm geometry. For example, the lockingcomponent (e.g., the lever or actuator) for locking the cannula to thearm may not be accessible in all configurations and the geometry of thearm might provide pinch points. The attachment device or dockinginterface 212 addresses some of these challenges by providing animproved configuration for attaching (e.g., docking) the cannula to thesurgical robotic arm which allows a user to grab the arm anywhere he/shewants, and provides audible, tactile, and visual feedback on the successof the task.

Representatively, as previously discussed, the attachment device ordocking interface 212 may include a fully mechanical locking assemblythat locks the device (e.g., lever 314 and/or first clamp component 306)in the open position (e.g., a lock-out position) and then allows thedevice 212 to automatically transition to a closed position (e.g. lockedposition) upon detecting that the cannula is inserted into the clamp inthe proper position. For example, the assembly may automaticallytransition through three states during docking of the cannula to therobotic arm. Representatively, the states may include 1) lock-out openposition that allows the user to signal to the system that “dockingmode” is process, 2) mechanical detection that the cannula is in thecorrect position for docking, and 3) automatic clamping of the cannulaand signaling to the user that the cannula is attached.

To transition the attachment device 212 through these states, the devicemay include lever 314 as previously discussed, which may also beinterchangeably referred to herein as a locking component or actuator.The lever or locking component 314 may be moveably coupled to the base420 and the first clamp component 306. For example, the lever or lockingcomponent 314 may be coupled to the base 420 and move relative to thebase at pivot point 422. The lever or locking component 314 may furtherbe coupled to the first clamp component 306 by a link 424 includingpivot points 426, 428 which allow the locking component 314 and thefirst clamp component 306 to move relative to one another. For example,as shown in FIG. 4A, when in the open (e.g., lock-out open position),the lever or locking component 314 is pivoted about pivot point 422 to arearward position (e,g, away from base 420). Due to the coupling of thelocking component 314 to the first clamp component 306 by link 424, thismovement, in turn, causes the first clamp component 306 to pivot aboutthe pivot point 402 in an upward direction (e.g., away from the opening304). In this aspect, the locking component 314 and/or the first clampcomponent 306 are in the open position and the cannula 404 can beinserted into the opening 304.

As previously discussed, the locking component 314 and first clampcomponent 306 are held (or locked) in this open position (e.g., thelock-out open position) until the cannula 404 is properly inserted intoopening 304. In this aspect, the device may further include a lock outmechanism 430 to hold or lock the locking component 314 and first clampcomponent 306 in this open position (e.g., the lock-out open position)until it mechanically detects proper insertion of the cannula. Forexample, the lock out mechanism 430 may be a trigger like mechanism thatincludes a hook 432 at one end and another end that is pivotally coupledto the base 420 at a pivot point 434. The hook 432 is configured to hookaround, or otherwise engage with, a bearing 436 attached to the lever orlocking component 314 when the locking component 314 is in the openposition, to hold the lever or locking component 314 (and first clampcomponent 306) in the lock-out open position. The lock out mechanism 430may further include a protruding member 438, which when contacted by acannula properly inserted and/or aligned within the opening 304, willcause the lock out mechanism 430 to disengage with the locking component314. This, in turn, allows the locking component 314 to automaticallytransition to the closed position. For example, the protruding member438 may be between the hook 432 and pivot point 434 and extend into theopening 304 when the lock out mechanism 430 is engaged with the lever orlocking component 314 (e.g., hook 432 is around bearing 436). When thecannula lug 406 is inserted within the opening 304 as shown in FIG. 4B,the cannula lug 406 will contact and push the protruding member 436 awayfrom the opening 304. This, in turn, causes the lock out mechanism 430to pivot in a rearward direction and the hook 432 to disengage with, orotherwise release, the locking component bearing 436. The lockingcomponent or lever 314 may be biased toward the closed position (e.g.forward position) by a spring 440 such that when it is released from thelock out mechanism 430, it automatically pivots forward (e.g, closer tothe base 420) to the closed position and attaches the cannula 404 to therobotic arm.

In some aspects, a proper docking position or alignment of the cannula404 (e.g., cannula lug 406) relative to the attachment device orinterface 212 must occur, or be otherwise detected, for the lockingcomponent 314 and/or clamping components 306, 308 to automaticallytransition from the lock-out open position to the closed position. Aproper docking or alignment position means the cannula is in a positionwithin the opening suitable for attachment to the surgical roboticsystem. An improper or misaligned position means the cannula is in aposition within the opening that is not suitable for attachment to thesurgical robotic system. For example, for the cannula 404 to be insertedfar enough into opening 304 for the cannula end 412 to contact anddisengage the lock out mechanism 430 from the lever 314 as previouslydiscussed, the cannula 404 must be in the proper docking or alignmentposition within opening 304. If the cannula 404 is not in the properdocking position or misaligned, the lock out mechanism 430 will notdisengage and the locking component 314 and/or clamping component 306will remain in the lock out position until a proper alignment or dockingposition is detected. The proper docking or alignment position of thecannula may therefore be considered mechanically detected by the system(e.g., detected by the attachment device or interface 212) when thecannula lug 406 contacts, or otherwise causes, the lock out mechanism430 to disengage from the lever 314. For example, in some aspects, theattachment device or interface 212 may include a particular shape and/orsurface feature that only mates with the cannula 404, and allows thecannula 404 to disengage the lock out mechanism 430 from the lever 314,when the cannula is in the docking position or otherwise properlyaligned within the opening 304. In further aspects, the cannula 404,more specifically the cannula lug 406, may be considered to have aparticular shape and/or surface feature that only mates with theattachment device or interface 212, and allows the cannula 404 todisengage the lock out mechanism 430 from the lever 314, when thecannula lug 406 is in a docking position or otherwise properly alignedwithin opening 304.

Representatively, in some aspects, the second clamping component 308 mayhave an alignment structure 444 which is in the shape of a slopedsurface. The alignment structure 442 may be capable of mating with, orotherwise being aligned with, a complimentary shaped alignment structure414 (e.g. sloped surface) on the bottom side of the cannula lug 406. Thealignment structures 444, 414 will be described in more detail inreference to FIGS. 10B-10C.

In still further aspects, the first clamping component 306 may includean alignment structure 442 which forms a triangular protrusion. Thealignment structure 442 may be capable of mating with, or otherwisebeing aligned with, a complimentary shaped alignment structure 408(e.g., recessed region) on the top side of the cannula lug 406. Forexample, the cannula 404 may be moved in a direction of the arrow suchthat the attachment portion 406 of the cannula 404 is inserted into theregion between the two clamp components 306, 308 or, more specifically,inserted through the opening 304 which is located in the region betweenthe two clamp components 306, 308. In some variations, the surface ofthe first clamp component 306 may be configured to help guide and orientthe attachment portion 406 when it is inserted into the region betweenthe two clamp components 306, 308. For example, the surface of firstclamp component 306 may be angled such that it smoothly receives theattachment portion 406 when the attachment portion 406 is inserted intothe region between the two clamp components 306, 308 in the predefinedorientation shown in FIG. 4A (e.g., in an orientation where thestructure 408 is facing the structure 442 to allow for engagementbetween the interfacing surfaces). When the attachment portion 406 isinserted into the region between the two clamp components 306, 308 in adifferent orientation, the structure 442 may push against or otherwiseinterfere with the attachment portion 406 to indicate that theattachment portion 406 is not properly orientated with respect to thetwo clamp components 306, 308. For example, the structure 442 mayprevent the attachment portion 406 from being inserted into the regionbetween the two clamp components 306, 308 (e.g., by creating a clearancethat is too small for the attachment portion 06 to be inserted into theregion) when the attachment portion 406 is not being inserted into theregion between the two clamp components 306, 308 in the predefinedorientation. In some variations, to help guide the attachment portion406 into the opening 304 between the two clamp components 306, 308, thestructures 442, 408 may have complimentary angles that mate with oneanother only when the attachment structure 406 is inserted into opening304 at a single orientation (e.g., the proper docking and/or alignmentposition).

In some aspects, the alignment structures 408, 414 of the cannula lug406 may be different such that the lug 406 is considered to have anasymmetrical shape which allows it to fit within the attachment device212 in only one position. In this aspect, when it is detected that thecannula lug 406 is in the proper docking or aligned position withinopening 304 (as shown in FIG. 4B), the device 212 automatically closesand clamps onto the cannula 404. This, in turn, solves an importantsurgical workflow problem by providing a fully mechanical and safesolution to docking a cannula to a robotic arm when access to themechanical lever is difficult or impossible. Additional alignmentstructures and configurations will be described in more detail inreference to FIGS. 10A-10C.

In some aspects, upon mechanically detecting that the cannula 404 is inthe proper docking position and/or that the device 212 has transitionedto the closed position, the system may further signal to the user thatthe cannula is in the docking position and/or the cannula is attached.For example, one or more of the previously discussed sensors (e.g.,sensor system 316 or switch 328) may detect that the device 212 is inthe closed position and signal to the user that the cannula is attached.In addition, the system may signal to the user whether the device 212 isin a docking mode or a clamping mode based on whether the device 212 isin the lock out open position or the closed position. The signal may bein the form of a message or other indicator on the system display, audiofeedback, haptic feedback or any other suitable notification to indicatethe state or mode of the system (or change in state or mode of thesystem) to the user. FIG. 5 illustrates an exemplary process flow forindicating to the user the state or mode of the device 212.Representatively, the process 500 may include providing a cannulaattachment device (e.g., 212) at operation 502, and then determiningwhether the device is in an open position at operation 504. For example,the device 212 may be determined to be in an open position if, forexample, the lever 314 or first clamping component 306 is in an openposition. If the device is determined to be in an open position, theuser is notified at operation 506 that the device is in the dockingmode. In other words, the user may still be positioning the cannulawithin the device opening and/or the cannula may be in the opening butnot yet properly aligned. If the device is not in the open position, theprocess continues on to determine whether the device is in the closedposition at operation 506. For example, the device 212 may be determinedto be in a closed position if, for example, the lever 314 or firstclamping component 306 is in the closed position. If the device isdetermined to be in the closed position, the user is notified atoperation 508 that the device is in the clamping mode or that thecannula is attached. If the device is still not determined to be in theclosed position at operation 506, this may mean that the user is stilltrying to properly position the cannula in the device therefore theprocess returns to operation 506 and notifies the user that the deviceis in the docking mode.

In still further aspects, the attachment device or docking interface mayinclude additional aspects that allow for detection of the presence ofthe cannula, proper latching onto the cannula, an angle of the lever,the type of cannula that has been attached or docked, and/or anyscenarios that could indicate cannula release. For example, sensors thatdrive a finite state machine to detect any one or more of the previouslymentioned scenarios or characteristics may be integrated into the device212 and/or the cannula 404. Each of these states can then becommunicated to the user using visual, audio, or other forms of feedbackon the robotic arm, as well as via any form of similar feedback on thesurgeon bridge. By way of background, it should be understood that whendocking a surgical robotic arm to a cannula there needs to be anaccurate way to sense that the cannula is: (1) properly docked to thearm with the attachment device completely closed; (2) to detect whichtype of cannula has been docked and communicate that to the system(e.g., Standard/Bariatric, 8 mm/12 mm); and (3) to monitor if thecannula is somehow released or becomes undocked. In this aspect, FIG. 6illustrates a schematic diagram of one representative sensor arrangementfor detecting any one or more of the previously mentioned scenarios orcharacteristics. Representatively, FIG. 6 illustrates at least onesensor 602 for detecting a characteristic of the locking component orlever 314 and at least one sensor 604 for detecting a characteristic ofthe cannula 404. In one aspect, the sensors 602, 604 may be magnetencoders and the lever 314 and the cannula 404 may include magnets 606,608, respectively, that are detected by the encoders.

The characteristic of the locking component or lever 314 detected by thesensor 602 may be an angle of the locking component or lever 314. Forexample, any angle within the range of angle (A) may be detected. Theangle of the locking component or lever 314 may further be used todetermine, for example, whether the lever 314 is open or closed, thecannula is properly docked, or other characteristics associated withcannula attachment. For example, if the lever 314 is detected at angle610, the system may determine the lever 314 is in the lock out openposition. On the other hand, if the lever 314 is detected at angle 612,the system may determine the lever 314 is in the closed position. Theangle may be measured relative to any point suitable for determining thelever position, for example the pivot point 436 or a center axis oflever 314.

Representatively, during operation, when the robotic arm is ready to bedocked to a cannula, the lever 314 may be manually moved to the openposition by the user and the lock out mechanism holds the lever 314 inthe open position as previously discussed. A detection of this movementby sensor 602 may be used by the system to determine that a gravitycompensated active back (GCAB) driving mechanism associated with thesurgical robotic arm should be engaged to allow the robotic arm to bepositioned at the docking interface or attachment device 212. Once therobotic arm is positioned and the cannula is pushed into the opening ofdevice 212, the lockout is disengaged allowing the latch to close andsecure the cannula to the arm as previously discussed. At this point thelever sensor 602 senses that the lever has been closed and has passedthe mechanical over-center point (e.g., is at an angle corresponding toposition 612). This information, may in turn, cause the system todisengage GCAB and hold the arm in that docked or attached position. Thesignal from sensor 602 may be actively monitored so that if the lever314 is accidentally depressed after the cannula is attached, the systemwill transition to an error state that should stop the procedure andnotify the user.

Referring now to the characteristics of the cannula 404 detected bysensor 604, representative characteristics may be, but are not limitedto, (1) a presence of the cannula 404 within the device 212 opening and(2) a type of cannula. For example, the cannula 404 may be determined tobe present when the cannula 404 is inserted into the opening such thatthe sensor 604 detects the magnet 608. The cannula 404 may be determinedto be absent when sensor 604 does not detect the magnet 608. Thepresence (or absence) of the cannula 404 may also be used to determine,for example, whether the cannula is properly docked and/or released. Forexample, if the presence of the cannula is detected by the cannulasensor 604 and the lever is determined to be in the closed positionbased on information from the lever sensor 602, the system may determinethe cannula is properly attached to the device (and the robotic arm). Onthe other hand, if the cannula presence is not detected by the cannulasensor 604 and the lever is determined to be in the open position basedon information from the lever sensor 602, the system may determine thatthe cannula has been released or is not properly attached to the device(and the robotic arm).

The type of cannula may be detected based on the angle of the magnet 608detected by sensor 604. In addition, sensing the magnetic orientationprovides an additional datapoint that the cannula is present and stablewithin the device 212, but mainly serves to provide specificidentification for the type of cannula that has been docked so thatinformation can be communicated to the robotic system and to the user.For example, each type of cannula 404 may have a magnet positioned at adifferent angle as illustrated by magnets 608A, 608B, 608C. The anglemay be, for example, an angle of the magnet's polar axis centerlinerelative to an orientation of magnet north pole. Therefore, when thesensor 604 detects the angled magnet 608A, angled magnet 608B or angledmagnet 608C, the system can match the angled magnet that is detected upwith the particular type of cannula it is associated with and notify theuser of the cannula type. Representative magnet field orientations thatcan be detected by the sensors, and their respective cannula types thatmay be determined by the system, are shown in Table 1 as follows:

Cannula Type Magnet Field Orientation Standard, 8 mm  30 degrees ± 14.5degrees Bariatric, 8 mm  90 degrees ± 14.5 degrees Standard, 12 mm 150degrees ± 14.5 degrees Bariatric, 12 mm 210 degrees ± 14.5 degrees

By monitoring the cannula type using sensor 604, there exists theopportunity to detect fake or incompatible cannulas as well as to sensea latching issue that might allow excessive movement of the cannulawithin the latching mechanism.

Moreover, the sensor 604 provides an additional signal that indicatesthat a certain magnetic threshold has been reached, which in turn, canbe used to confirm the presence of cannula 404 in device 212. While thisis also achieved by having a valid cannula type or identificationreading as previously discussed, this signal is a more definitive binaryvalue and may be the main signal used for cannula presence. Loss of thissignal at any point in time may indicate a release of the cannula andmay cause the system to transition to an error state that would stop theprocedure and notify the user.

As previously discussed in reference to FIG. 3, sensors 602, 604 may beelectrically connected to a sensor board 320 positioned within thedevice opening 304, or could be positioned in any location of device 212suitable for detected the desired characteristics. The sensor board 320can include a microprocessor or other associated processor 614, forexample, to control and/or read the sensors 602, 604 of the sensor board320, to facilitate communication of information from the sensors 602,604 to the user, and to determine one or more of the previouslydiscussed characteristics based on the sensor information. In addition,although sensor 604 is described as a single sensor that outputs twoseparate signals indicating cannula presence and type, different sensorsfor detecting each of these characteristics separately could be used.Still further, although only two sensors 602, 604 are illustrated, it iscontemplated that at least four sensors or more may be used to provideredundancy for safety reasons.

Referring now in more detail to the system operation based on theinformation detected by the previously discussed sensors, FIG. 7illustrates one representative process. In one aspect, process 700includes an initial state or mode in which the system is consideredready for cannula docking at operation 702. For example, the system maybe considered ready for cannula docking when the system (e.g., a sensor)detects that the attachment device or interface device 212 is in thelock-out open position such that it is ready for cannula insertion(e.g., lever 314 is engaged with the lock out mechanism 430 and lever314 and/or first clamp 306 is in the open position) and/or no cannula isdetermined to be present. Once it is determined the system is ready forcannula docking at operation 702, one or more associated processors maycause the surgical robotic system to disengage a braking assemblyassociated with a surgical robotic arm, and engage a gravity compensatedactive back (“GCAB”) driving mechanism associated with the surgicalrobotic arm to allow for positioning of the cannula within a clampingassembly associated with a surgical robotic arm at operation 704. Inaddition, once GCAB is engaged, if the system (e.g., sensor assembly)detects a transition of the clamp assembly (e.g., a lever 314 or clamp306 of attachment device 212) to the closed position and/or that thecannula is not present within the clamp assembly, the process returns tooperation 702. For example, the one or more processors may cause thesurgical robotic system to engage the braking assembly associated withthe surgical robotic arm and disengage the GCAB driving mechanismassociated with the surgical robotic arm so that a current position ofthe cannula relative to the clamping assembly is maintained.Alternatively, once GCAB is engaged, if the system (e.g., sensorassembly) detects a transition of the clamp assembly to the closedposition and the cannula is present, the system determines that thecannula has been inserted into the clamping assembly and the one or moreprocessors may cause the surgical robotic system to notify a user thatthe cannula is inserted at operation 706. In addition, once the cannulais detected and the system recognizes that it is inserted at operation706, the system may further determine the type of cannula that wasinserted and notify the user of the type of cannula. For example, thesensor assembly associated with the attachment device may determine thetype of cannula based on a magnet orientation as previously discussed.Once it is determined at operation 706 that the cannula is properlyinserted, the system may notify the user that the cannula is docked, orotherwise attached to the attachment or clamping assembly of thesurgical robotic arm, at operation 708. In addition, if once it isdetermined at operation 706 that the cannula is inserted, but then thesystem senses that the clamping assembly is open, the cannula presenceis not detected, or the cannula identifier (ID) cannot be detected, thesystem may engage the braking assembly and return to operation 702. Inaddition, the system may notify the user that the latch is now openand/or the cannula is not detected, therefore an error may have occurredand the procedure has been stopped. In other words, the system maynotify the user that the system is ready for a cannula to be attached.In this aspect, the sensor assembly integrated into the attachmentdevice (or clamping assembly) is used to drive a finite state machine todetect presence of the cannula, proper latching onto the cannula, thetype of cannula that has been docked, and any scenarios that couldindicate cannula release. Each of these states can then be communicatedto the user using visual, audio, or other forms of feedback on therobotic arm, as well as via any form of similar feedback on the surgeonbridge.

Returning now to additional aspects of the attachment device, FIGS.8A-8B illustrates an over-center configuration of the attachment device.FIGS. 8A-8B illustrate the same attachment device or interface 212described in reference to FIGS. 4A-4B, however the over-centerconfiguration is now shown in more detail. The over-center configurationensures a reliable and secure attachment of the cannula to the surgicalrobotic arm while also allowing a user to disconnect and reconnect thetwo items whenever necessary. For example, the over-center configurationmay prevent the attachment or clamping mechanism (e.g., the lever) frombeing back driven to an open position by forces applied to the cannula.Once over center, the lever will increasingly force itself closed withany increasing load applied to the cannula. This helps to ensure thecannula is held securely and reliably to the robotic arm during surgery.Representatively, FIG. 8A illustrates the attachment device or interface212 in the lock out open position as previously discussed in referenceto FIG. 4A. In this open position, the attachment device or interface212 is not considered to be in the over-center configuration. FIG. 8Billustrates the attachment device or interface 212 in the closedposition as previously discussed in reference to FIG. 4B. For example,in the closed position, the actuator or lever is all the way forwardresting against the base. For example, the actuator or lever pushes thefirst clamp component forward which then clamps the cannula lug againstthe second clamp component and holds it securely in the attachmentdevice or interface 212. In this closed position, the attachment deviceor interface 212 is considered to be in the over-center configurationbecause the associated four bar linkage mechanism is designed toover-center.

Representatively, as previously discussed, attachment device orinterface 212 includes a locking component, actuator or lever 314 thatis movably connected to the base 420 at pivot point 422 near one end,which allows the other end of lever 314 to move between the openposition (rearward position) and closed position (forward position). Inone aspect, end 314A of lever 314 moves between the open/closedpositions and may be manually controlled by the user. The pivot point422 may be near the other end 314B of lever 314, which may be coupled tothe lock out mechanism when the device is in the open lock out position.In addition, the first clamp component 306 is movably connected to thebase 420 at pivot point 402 at one end 306A, which allows the other end306B of the first clamp component 306 to move between the open(non-clamping) position and the closed (clamping) position. The lever314 and the first clamp component 306 are also movably connected to eachother by the link 424. The link 424 is connected to the lever 314 atpivot point 428 at one end and the first clamp component 306 at pivotpoint 426. In other words, the linkage mechanism of device 212 mayinclude at least four pivot points 402, 422, 426 and 428 which form afour bar linkage mechanism. The linkage mechanism pivot points maytherefore also be referred to herein as first pivot point 426, secondpivot point 428, third pivot point 402 and fourth pivot point 422.During operation, at the beginning of the closing stroke (e.g., lever314 moving in a forward direction toward base 420 as illustrated by thearrow), pivot point 426 (e.g., first pivot point) leads pivot point 428(e.g., second pivot point) through the rotation of the mechanism. As themechanism nears its fully closed position, pivot point 428 (e.g., secondpivot point) overtakes pivot point 426 (e.g., first pivot point) asshown in FIG. 8B, at which point the attachment device 212 (e.g lever314) is said to be over-center. For example, in some aspects, theattachment device 212 may be considered to be fully closed (or latched)when pivot point 428 (e.g., second pivot point) is over center relativeto pivot point 426 (e.g., first pivot point) by an over center angle(OCA) of one degree or less, or at least one degree. This particularover center angle (OCA) is critical to ensuring that the device does infact over center, yet does not reach an over center angle that is soextreme that clamping force on the cannula lug begins to decrease. Aspreviously discussed, as a result of this over center configuration, theattachment device will increasingly force itself closed (e.g., firstclamp component 306) with any increasing load applied to the cannula.

The lock out mechanism for holding the attachment device in the lock outopen position will now be described in more detail in reference to FIGS.9A-9D. Representatively, FIG. 9A-9B illustrate magnified cross sectionalside views of the lock out mechanism, and FIGS. 9C-9D illustratemagnified cross sectional side views of an adjustment mechanism of thelock out mechanism of FIGS. 9C-9D. The lock out mechanism of FIGS. 9A-9Dmay be substantially the same as, and therefore include the samefeatures as, lock out mechanism 430 described in reference to FIGS.4A-4B. Certain features of the lockout mechanism may, however, beomitted from FIGS. 9A-9D for the sake of clarity.

Referring now in more detail to FIG. 9A, lock out mechanism 430 may be atrigger type locking mechanism which includes a hook 432 at one end andanother end that is pivotally coupled to the attachment device base atpivot point 434. Hook 432 is configured to hook around, or otherwiseengages with, the bearing 436 of the lever 314 to hold the lever 314(and the associated clamping component) in the lock out open position.The lock out mechanism 430 further includes protruding member 438between the hook 432 and pivot point 434, and a spring 902 at the pivotpoint 434. The spring 902 may bias the lock out mechanism 430 toward thelock out open position (e.g., a position in which hook 432 is hookedaround bearing 436). The protruding member 438 may face the attachmentdevice opening and be pressed by the cannula during insertion causingthe lock out mechanism 430 to pivot as shown by the arrow at pivot point434, and the hook 432 to unhook, or otherwise disengage with, thebearing 436 of the lever 314. This, in turn, allows the attachmentdevice to automatically transition to the closed position because it isbiased toward the closed position (e.g., the first clamp component toclamp onto the cannula), as previously discussed.

The lockout mechanism 430 may be actuated in this manner tens ofthousands of times. Various components of the lock out mechanism 430 aretherefore selected or configured to withstand such use without wearingout or becoming unreliable. Representatively, to prevent the interfacebetween the hook 432 of the lock out mechanism 430 and the bearing 436of the lever 314 from becoming worn out over time, the bearing 436 maybe a ball bearing that is able to roll along the surface of the hook 432instead of sliding. For example, if the hook 432 were to hook around afixed structure instead of balling bearing 436, the two structures wouldslide along each other until they become disengaged and the triggerreleases. This sliding action can wear out these interfacing surfacesover time. The lock out mechanism 430 therefore includes ball bearing436 which rotates with any triggering action and movement of the hook432 to ensure that there are no static metal surfaces rubbing andwearing against each other.

In addition, the hook 432 may be configured to reduce wear and improvereliability. For example, the geometry of hook 432 is selected to engageand disengage with the bearing 436 as necessary with minimal wear at theinterface. Representatively, referring now to FIG. 9B, FIG. 9B is amagnified view of the hook/bearing interface section shown with dashedlines in FIG. 9A. As can be seen from FIG. 9B, when the lock outmechanism 430 is engaged and waiting to be triggered, the tip 904 of thehook 432 is above (or beyond) the tangent point 906 of the bearing 436.This positions hook 432 so that the bearing 436 is fully nested withinthe hook 432. When the lockout mechanism 430 begins to be triggered andmoves along its rotational path 912, the hook tip 904 moves in adisengagement direction 908 and nears the tangent point 906 of thebearing 436. Once the hook tip 904 reaches that tangent point 906, thebearing 436 will rapidly rotate causing the lock out mechanism 430,which is biased by the spring 902 to disengage the bearing 436, torelease the bearing 436. Once released, the bearing 436 moves alongrotation path 914 (as a result of the lever 314 rotation about pivotpoint 422) so that the lever 314 (and first clamp component) canautomatically transition to the closed position. The lock out mechanism430 reengages with the lever 314 when the hook tip 904 is caused to movein the engagement direction 910 and passes the tangent point 906 (e.g.extends beyond the tangent point 906). Accordingly, the geometry of hook432 may be selected so that it conforms to the bearing 436 outer surface(e.g., curved) and has a depth (D), as measured from tip 904 to thebottom of the hook 916, that allows tip 904 to extend beyond the bearingtangent point 906 when the bearing is fully seated within the hook 432.In addition, as previously discussed, throughout this entire process,the hook 432 is biased by spring 902 into the engaged position to ensurethat the trigger does not release until it is purposely triggered. Theweight of the spring 902 may therefore also be selected to providesecure engagement without having a noticeable impact on the forcerequired to release the lock out mechanism 430.

In still further aspects, the lock out mechanism 430 may provide audibleand/or haptic feedback when it is engaged/disengaged. For example, whenthe bearing 436 is released from the hook 432, the rolling action allowsthe bearing to smoothly snap out of the hook and produce an audibleand/or haptic feedback notifying the user that the mechanism has beenreleased. In addition, when the lock out mechanism 430 is re-engaged,the bearing 436 may act the same way as it does upon release and therolling action of the bearing allows the hook to smoothly snap back intoplace providing the feedback.

In addition, in some aspects, the force needed to trigger the lock outmechanism may be adjustable. As previously discussed, the lock outmechanism has a number of usability advantages within the dockingworkflow. The force needed to trigger the lock out mechanism andcomplete docking is critical to the workflow. Too much of a forcerequirement makes it too difficult for the surgical staff to completethe docking procedure, whereas too little of a force requirement couldlead to inadvertent triggering of the lock out mechanism and prematureclosing of the latch before docking is complete. Being able to adjustthis force during assembly allows it to be tuned to the exact level thatis desired from a usability perspective.

A representative force adjustment mechanism is shown in FIGS. 9C-9D.Force adjustment mechanism 920 may, in some aspects, be a mechanism orstructure that biases lock out mechanism 430 towards disengagement whentightened. For example, force adjustment mechanism 920 may, in someaspects, be a set screw. The set screw may extend through the lock outmechanism 430 and into the interface between the hook/bearing interfacewhen tightened in the direction of arrow 922, as illustrated in FIG. 9C.Representatively, as the lockout adjustment set screw is tightened, itpresses against the lockout bearing 436 and shifts the hook 432 suchthat it has less engagement with the lockout bearing 436 than before itwas tightened. In other words, the distance (D1) between the bottom 916of the hook 432 and the bearing 436 increases. This shortens thedistance that the hook 432 has to travel to become disengaged and, inturn, the force required to disengage the lock out mechanism 430 islowered. The opposite can be achieved by loosening the set screw in thedirection of arrow 924, as shown in FIG. 9D. In particular, as shown inFIG. 9D, when the screw is loosened, the distance (D2) between the hook432 and bearing 436 decreases, resulting in more engagement between thehook 432 and bearing 436. This results in an increase in the forcerequired to disengage the lock out mechanism 430. The position of theadjustment mechanism 430 can be set after assembly of the attachmentdevice and the actuation force can be confirmed before assembling themechanism into the robotic arm.

In addition, as previously discussed, the interface between the clampingcomponents and the cannula may also play an important role in ensuring asecure attachment between the cannula and the attachment device (and theassociated surgical robotic arm). Specific aspects of somerepresentative clamp/cannula alignment or interface structures will nowbe described in more detail in reference to FIGS. 10A-10C. Although notshown, it should be understood that the attachment device or interfacedescribed in reference to FIGS. 10A-10C, although not shown and/orcertain parts are omitted, may be substantially the same as theattachment device or interface 212 previously discussed in reference toFIG. 4A-4B.

FIG. 10A illustrates a cross-sectional side view of one aspect of aninterface or alignment structure of the cannula lug. Representatively,as previously discussed in reference to FIGS. 4A-4B, atop side of thecannula lug 406 may include alignment structure 408. From this view, itcan be seen that alignment structure 408 may be considered to have areverse taper that is formed by sloped surfaces 1002, 1004. The slopedsurface 1002, 1004 form a triangular shaped recessed region within thetop side of cannula lug 406. First clamp component 306 may, in turn,include a complimentary cannula mating structure 442 which interfaceswith structure 408 when the clamp is in the closed position. Forexample, the mating structure 442 may be a triangular shaped end that isat an angle designed to pull the cannula lug 406 into the attachmentdevice. For example, the reverse taper formed by the structure 408combined with the angle of clamp structure 442 is designed to pull thecannula lug 406 into the latch in a direction of arrow 1006 when firstclamp component 306 is closed to ensure that the cannula is fully seatedwithin the attachment device. The angle of the interface of structures408, 442 also keeps the cannula 404 securely seated in the attachmentdevice (and against the second clamp component 308) when external forceson the cannula 404 may try to pull it up and out of the attachmentdevice.

FIG. 10B-10C illustrate perspective views of another aspect of aninterface or alignment structure the cannula lug. Representatively, aspreviously discussed in reference to FIGS. 4A-4B, a bottom side of thecannula lug 406 may include alignment structure 414 which interfaceswith an alignment structure 444 of the second clamp component 308. Fromthis view, it can be seen that alignment structure 414 may include akeel shaped protrusion 1008 formed in the bottom side of the cannula lug406. The keep shaped protrusion 1008 may be formed by a bottom wall1008A and side walls 1008B. It should be understood that due to theperspective view, the second side wall 1008B is hidden from view. Thebottom wall 1008A may taper inward toward the cannula body 416 such thata width (W1) near end 414 is wider than a width (W2) near body 416. Inaddition, side walls 1008B may taper inward toward the end 412 so thatthe structure 414 is sloped as shown in FIG. 10A. The interfacing orcomplimentary alignment structure 444 on the top side of the secondclamp component 308 may, in turn, include a recessed region 1010 havinga complimentary configuration to protrusion 1008 so that protrusion 1008can be inserted within recessed region 1010. Representatively, recessedregion 1010 may be formed by a bottom wall 1010A that tapers inward fromend 1012 to end 1014, and side walls 1010B that are tapered inwardtoward the end 1012 so that is complimentary to structure 414. Thiscomplimentary configuration of structures 414, 444 helps to guide theinsertion of the cannula 404 into the attachment device 212 as well asproviding rotational stability. In addition, this configuration helpsprevent deflection or twisting of the cannula lug 406 within theattachment device 212 when the cannula 404 is side loaded.

Returning now to the sterile adapter previously discussed briefly inreference to FIG. 4A-B, the particular details of the sterile adapterwill now be described in reference to FIGS. 11A-11D. Representatively,FIGS. 11A-11B illustrate bottom and top perspective views of a sterileadapter, respectively. FIGS. 11C-11D illustrate cross-sectional sideview of the sterile adapter illustrated in FIGS. 11A-11B serving as abarrier between the cannula and the attachment device. As previouslydiscussed, the sterile adapter is necessary to maintain the sterilebarrier between the robotic arm and the surgical field. The cannula mustbe rigidly secured through the sterile barrier, however, an entirelyrigid or entirely flexible barrier may make it challenging for theattachment device to securely clamp onto the cannula. To solve thesechallenges, sterile adapter 450 is configured to have hard plasticregions molded together with flexible elastomer regions to form a moldedsterile barrier that is both rigid and flexible. The hardplastic/flexible elastomer sterile barrier 450 may be formed by, forexample, over molding the rigid plastic pieces to form the rigidportion(s) and then over molding a soft flexible elastomer such asthermoplastic polyurethane (TPU) between the plastic pieces. In thisaspect, any rigid plastic pieces that are not directly molded togetheras a single rigid piece, are connected with the single rigid piece bythe flexible elastomer resulting in an integrally formed sterile barrierhaving inseperable rigid and flexible portions. Representatively, thesterile adapter 450 may include a rigid barrier portion 1102 molded to aflexible barrier portion 1104, which in combination, surround thecannula lug and provide a sterile barrier between the attachment device212 on one side and the cannula 404 on the other. The rigid barrierportion 1102 may include a cannula interface portion 1106 that definesthe opening 452 through which the cannula lug is inserted. The cannulainterface portion 1106 may be a substantially flat or plate like memberthat includes one side that faces the cannula (e.g., cannula side 1108)and an opposite side that faces the attachment device and/or surgicalrobotic arm (e.g., arm side 1110) when it is inserted into theattachment device opening (e.g., opening 314 of device 212 as shown inFIG. 4A-B). The rigid barrier portion 1102 may also include an alignmentinterface portion 1112 and an exterior alignment portion 1013 thatextend from opposing sides of the cannula interface portion 1106. Forexample, the exterior alignment portion 1013 may be a lip that extendsfrom the cannula side 1108 of the cannula interface portion 1106 and thealignment interface portion 1112 may extend from the arm side 1110 ofrigid portion 1102 and into the device opening (e.g., opening 314 ofdevice 212). The alignment interface portion 1112 may include a matingfeature or alignment structure 1114 that is dimensioned to mate with analignment structures of the cannula lug and second clamp component.Representatively, the alignment structure 1114 may be configured to bepositioned between and mate with the alignment structures 414 and 444 ofthe cannula lug 406 and second clamp component 308, as previouslydiscussed in reference to FIGS. 4A-B and FIGS. 10B-C. In this aspect,the alignment structure 1114 may be on or form the bottom side of thesterile adapter 450 so that it can mate with the structures 414, 444.Alignment structure 1114 may be as rigid and exact as possible so thatminimal compression occurs and no clamping force on the cannula lug islost. For example, similar to alignment structure 444, alignmentstructure 1114 may be formed by a tapered bottom wall 1114A, and taperedside walls 1114B so that it can receive the alignment structure 414.

In addition, as can be seen from the top perspective view of FIG. 10B,the opposite (or top side) of the sterile adapter 450 includes anotherrigid alignment structure 1116 that interfaces with the clampingcomponent during a clamping operation. Representatively, the top siderigid alignment structure 1116 may be configured to align with, orotherwise interface with, the alignment structure 442 of the first clampcomponent 306 and the alignment structure 408 of the cannula lug 406(see FIGS. 4A-B and FIG. 10A), during a clamping operation. The top sidealignment structure 1116 may therefore have any size, shape that allowsit to interface with structures 408, 442. For example, top sidealignment structure 1116 may have a similar size and shape to structure408 or structure 442, for example, an elongated shape, a polygon shapeor any other suitable shape. The top side alignment structure 1116 madeof a same material as the rest of the rigid portion 1102 and be designedto have as little compression as possible since this is the surface thatthe clamp contacts when clamping against the cannula lug and anycompression would result in a reduction in clamping force and retention.The top side alignment structure 1116, however, is entirely surroundedby the flexible barrier portion 1104 to allow for the top side alignmentstructure 1116 to be able to rotate to the angle of the clamp/luginterface area (e.g., angles between alignment structures 442 of clamp306 and structure 408 of lug 406) as easily as possible. The modifiableangle of the top side alignment structure 1116 is illustrated in moredetail in reference to FIGS. 11C-D. In particular, in FIG. 11C, it canbe seen that when the attachment device 212 and first clamp component306 are in the open configuration, the top side alignment structure 1116may be substantially aligned with, and form a substantially flat surfacewith, the remainder of the sterile adapter top side formed by thesurrounding flexible barrier portion 1104. When, however, the firstclamp component 306 is moved to the closed configuration as shown inFIG. 11D, the first clamp component 306 presses on the top sidealignment structure 1116. This, in turn, presses the top side alignmentstructure 1116 against the surface 1002 of alignment structure 408 ofcannula lug 406. In other words, the top side alignment structure 1116rotates downward and becomes angled relative to the rest of the top sideso that it matches the angle of the surface 1002 of the forming thealignment structure 408 of the cannula lug 406. This can occur becausethe top side alignment structure 1116 is entirely surrounded by theflexible barrier portion 1104. For example, the flexible barrier portion1104 may act as a hinge allowing the top side alignment structure 1116to change positions. The rigid/flexible nature of this portion of thesterile adapter 450 is important as the shape of the sterile adapter inthe open position is designed to make insertion and removal of thecannula as easy as possible, yet the flexible design ensures that theimportant mating surfaces of the sterile adapter can conform to thenecessary shape for secure attachment (e.g., clamping) with as littleforce as necessary and as reliably as possible.

Returning now to the flexible barrier portion 1104, as previouslydiscussed the flexible barrier portion is molded to the rigid portion1102 and is configured to surround the remainder of the cannula lug. Inthis aspect, the flexible barrier portion 1104 may be molded to, andextend from, the arm side 1110 of the rigid cannula interface portion1106 and around the opening 452. In this aspect, the flexible barrierportion 1104 may form a cavity 1120 around the opening 452 of the rigidinterface portion 1106 that is dimensioned to receive the cannula lug.The cavity 1120 may have a bottom side defined by the rigid alignmentportion 1114, a portion of the top side defined by the rigid alignmentportion 1116 and the remainder of the cavity is substantially defined bythe flexible barrier portion 1104.

Additional aspects of the sterile adapter 450 may include a rigidretention bump 1130 molded to the arm side 1110 of the rigid interfaceportion 1106 and positioned along the top side of the flexible barrierportion 1104. The retention bump 1130 may, for example, mate with acomplimentary mating structure near the opening of attachment device 212to help to keep the sterile adapter seated in the attachment device 212during cannula insertion and removal. In addition, the sterile adapter450 may include one or more rigid mating datums 1132 molded to the armside of the rigid cannula interface portion 1106 and positioned along aside of the flexible barrier portion 1104. For example, at least onedatum(s) 1132 may be positioned along a side of the adapter differentfrom the bump 1130, and/or the top side and bottom side, for example, toa third side that connects the top side and the bottom sides. The rigidmating datum(s) 1132 may be configured in a particular orientationdesigned to keep the cannula correctly aligned with the tool axis.

FIG. 12 is a block diagram of a computer portion of a surgical roboticsystem, which is operable to implement the previously discussedoperations, in accordance with an embodiment. The exemplary surgicalrobotic system 1200 may include a user console 102, a surgical robot120, and a control tower 103. The surgical robotic system 1200 mayinclude other or additional hardware components; thus, the diagram isprovided by way of example and not a limitation to the systemarchitecture.

As described above, the user console 102 may include console computers1211, one or more UIDs 1212, console actuators 1213, displays 1214, footpedals 1216, console computers 1211 and a network interface 1218. Inaddition, user console 102 may include a number of components, forexample, a UID tracker(s) 1215, a display tracker(s) 1217 and a consoletracker(s) 1219, for detecting various surgical conditions required foroperation of the system (e.g., UID orientation, orientation of thesurgeon relative to the display, orientation the console seat, etc). Itshould further be understood that a user or surgeon sitting at the userconsole 102 can adjust ergonomic settings of the user console 102manually, or the settings can be automatically adjusted according touser profile or preference. The manual and automatic adjustments may beachieved through driving the console actuators 1213 based on user inputor stored configurations by the console computers 1211. The user mayperform robot-assisted surgeries by controlling the surgical robot 120using one or more master UIDs 1212 and foot pedals 1216. Positions andorientations of the UIDs 1212 are continuously tracked by the UIDtracker 1215, and status changes are recorded by the console computers1211 as user input and dispatched to the control tower 103 via thenetwork interface 1218. Real-time surgical video of patient anatomy,instrumentation, and relevant software apps can be presented to the useron the high resolution 3D displays 1214 including open or immersivedisplays.

The user console 102 may be communicatively coupled to the control tower103. The user console also provides additional features for improvedergonomics. For example, the user console may be an open architecturesystem including an open display, although an immersive display, in somecases, may be provided. Furthermore, a highly-adjustable seat forsurgeons and master UIDs tracked through electromagnetic or opticaltrackers are included at the user console 102 for improved ergonomics.

The control tower 103 can be a mobile point-of-care cart housingtouchscreen displays, computers that control the surgeon'srobotically-assisted manipulation of instruments, safety systems,graphical user interface (GUI), light source, and video and graphicscomputers. As shown in FIG. 12, the control tower 103 may includecentral computers 1231 including at least a visualization computer, acontrol computer, and an auxiliary computer, various displays 1233including a team display and a nurse display, and a network interface1218 coupling the control tower 103 to both the user console 102 and thesurgical robot 120. The control tower 103 may offer additional featuresfor user convenience, such as the nurse display touchscreen, soft powerand E-hold buttons, user-facing USB for video and still images, andelectronic caster control interface. The auxiliary computer may also runa real-time Linux, providing logging/monitoring and interacting withcloud-based web services.

The surgical robot 120 may include an operating table 1224 with aplurality of integrated robotic arms 1222 that can be positioned overthe target patient anatomy. A suite of compatible tools 1223 can beattached to or detached from the distal ends of the arms 1222, enablingthe surgeon to perform various surgical procedures. The surgical robot120 may also comprise control interface 1225 for manual or automatedcontrol of the arms 1222, table 1224, and tools 1223. The controlinterface can include items such as, but not limited to, remotecontrols, buttons, panels, and touchscreens. Other accessories such astrocars (sleeves, seal cartridge, and obturators) and drapes may also beneeded to perform procedures with the system. In some variations, theplurality of the arms 1222 includes four arms mounted on both sides ofthe operating table 1224, with two arms on each side. For certainsurgical procedures, an arm mounted on one side of the table can bepositioned on the other side of the table by stretching out and crossingover under the table and arms mounted on the other side, resulting in atotal of three arms positioned on the same side of the table 1224. Thesurgical tool can also comprise table computers 1221 and a networkinterface 1218, which can place the surgical robot 120 in communicationwith the control tower 103.

The foregoing description, for purposes of explanation, used specificnomenclature to provide a thorough understanding of the invention.However, it will be apparent to one skilled in the art that specificdetails are not required in order to practice the invention. Thus, theforegoing descriptions of specific aspects of the invention arepresented for purposes of illustration and description. They are notintended to be exhaustive or to limit the invention to the precise formsdisclosed; obviously, many modifications and variations are possible inview of the above teachings. The embodiments were chosen and describedin order to best explain the principles of the invention and itspractical applications, and they thereby enable others skilled in theart to best utilize the invention and various embodiments with variousmodifications as are suited to the particular use contemplated.

What is claimed is:
 1. An apparatus for attachment of a cannula to arobotic surgical system, the apparatus comprising: a clamp operable totransition between an open position configured to receive a cannula anda closed position to attach the cannula to a robotic surgical system; anactuator operable to transition the clamp between the open position andthe closed position; and a linking member pivotally coupled to the campat a first pivot point and the actuator at a second pivot point, andwherein in the closed position, the second pivot point is over centerrelative to the first pivot point.
 2. The apparatus of claim 1 whereinin the closed position, the second pivot point is over center relativeto the first pivot point by an angle of one degree or less.
 3. Theapparatus of claim 1 wherein having the second pivot point over centerrelative to the first pivot point causes the clamp to increasingly forceitself to the closed position with any increasing load applied to thecannula attached to the robotic surgical system.
 4. The apparatus ofclaim 1 wherein having the second pivot point over center relative tothe first pivot point prevents the clamp from transitioning to the openposition when a force is applied to the cannula attached to the roboticsurgical system.
 5. The apparatus of claim 1 wherein the clamp comprisesa first end rotatably coupled to a base member at a third pivot pointand a second end that rotates to a forward position to attach thecannula to the robotic surgical system.
 6. The apparatus of claim 5wherein the second end comprises a cannula mating feature configured toreinforce the attachment of the cannula to the robotic surgical system.7. The apparatus of claim 5 wherein the actuator is coupled to the basemember at a fourth pivot point to form a four bar linkage mechanism. 8.The apparatus of claim 7 wherein the actuator comprises a first endconfigured to allow a user to manually cause the actuator to transitionthe clamp to the open position and a second end proximate to a lockoutmechanism, wherein the lock out mechanism engages with the actuator tolock the clamp in the open position, and disengages with the actuator toallow the clamp to transition to the closed position upon beingcontacted by the cannula.
 9. The apparatus of claim 1 further comprisinga base member having a cannula receiving chamber within which thecannula is positioned when attached to the robotic surgical system bythe clamp, and wherein the receiving chamber comprises a cannula matingfeature to guide the cannula into the receiving chamber and preventmisalignment of the cannula.
 10. A cannula sterile adapter forattachment of a cannula to a robotic surgical system, the adaptercomprising: a rigid barrier portion having a cannula interface definingan opening dimensioned to receive a cannula lug, a first cannulainterface structure extending from the cannula interface, and a secondcannula interface, the first cannula interface and the second cannulainterface are dimensioned to interface with alignment structures of acannula lug; and a flexible barrier portion molded to the rigid barrierportion, the flexible barrier portion defining a cavity around theopening of the rigid barrier portion that is dimensioned to receive acannula lug inserted therein, the cavity having a first side defined bythe first cannula interface structure and a second side along which thesecond cannula interface structure is position, and wherein the secondcannula interface structure is entirely surrounded by the flexiblebarrier portion.
 11. The adapter of claim 10 wherein the cannulainterface comprises a plate having an arm side that faces a roboticsurgical arm of the robotic surgical system and a cannula side thatfaces the cannula lug, and the first cannula interface structure extendsfrom the arm side in a direction of the robotic surgical arm.
 12. Theadapter of claim 10 wherein the flexible barrier portion is molded tothe arm side of the plate and defines at least three sides of thecavity.
 13. The adapter of claim 10 wherein the first cannula interfacestructure comprises a keel shaped structure dimensioned to interfacewith a complimentary recessed region of the cannula lug.
 14. The adapterof claim 10 wherein the rigid clamp interface portion comprises a platemolded to the second side.
 15. The adapter of claim 14 wherein an angleof the plate is modifiable to an angle of the alignment structures ofthe cannula lug.
 16. The adapter of claim 10 further comprising aretention bump coupled to the second side of the flexible barrierportion, the retention bump dimensioned to retain the cannula sterileadapter within a clamping assembly during insertion and removal of thecannula lug within the clamping assembly.
 17. The adapter of claim 10further comprising a mating datum coupled to a third side of theflexible barrier portion and configured to maintain an alignment betweenthe cannula lug inserted therein and an axis of an associated tool. 18.The adapter of claim 10 wherein the rigid barrier portion is formed by aplastic material.
 19. The adapter of claim 10 wherein the flexiblebarrier portion is formed by a flexible elastomeric material that isovermolded to the rigid barrier portion.
 20. The adapter of claim 10wherein the flexible barrier portion comprises thermoplasticpolyurethane.